AMINOPHYLLINE INJ 25MG/ML

Main information

  • Trade name:
  • AMINOPHYLLINE INJ 25MG/ML LIQUID
  • Dosage:
  • 25MG
  • Pharmaceutical form:
  • LIQUID
  • Composition:
  • AMINOPHYLLINE 25MG
  • Administration route:
  • INTRAVENOUS
  • Units in package:
  • 10/20ML
  • Prescription type:
  • Prescription
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • AMINOPHYLLINE INJ 25MG/ML LIQUID
    Canada
  • Language:
  • English

Therapeutic information

  • Therapeutic area:
  • RESPIRATORY SMOOTH MUSCLE RELAXANTS
  • Product summary:
  • Active ingredient group (AIG) number: 0102399003; AHFS: 86:16.00

Other information

Status

  • Source:
  • Health Canada
  • Authorization status:
  • MARKETED
  • Authorization number:
  • 00497193
  • Authorization date:
  • 31-12-1985
  • Last update:
  • 14-03-2019

21-3-2019

FDA Announces New Date for Webinar on Genome Editing in Animals

FDA Announces New Date for Webinar on Genome Editing in Animals

On April 25, 2019, FDA CVM, with participation from the CBER, will hold a public webinar about genome editing in animals, an innovative and rapidly evolving technology that offers significant public health benefits.

FDA - U.S. Food and Drug Administration

21-3-2019

Modification of the existing maximum residue levels for pyridaben in tomatoes and aubergines

Modification of the existing maximum residue levels for pyridaben in tomatoes and aubergines

Published on: Wed, 20 Mar 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Nissan Chemical Europe S.A.S. submitted a request to the competent national authority in the Netherlands to modify the existing maximum residue levels (MRLs) for the active substance pyridaben in tomatoes and aubergines. An MRL proposal of 0.15 mg/kg was derived for tomatoes and aubergines which reflects the intended use of the plant protection product containing pyridaben. Adequate analytical metho...

Europe - EFSA - European Food Safety Authority EFSA Journal

21-3-2019

Modification of the existing maximum residue level for cyprodinil in Florence fennel

Modification of the existing maximum residue level for cyprodinil in Florence fennel

Published on: Wed, 20 Mar 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the FPS Health, Food chain safety and Environment of Belgium, submitted an application to modify the existing maximum residue level (MRL) for the active substance cyprodinil in Florence fennel to accommodate the intended use in the northern Europe. The submitted data were found sufficient to derive an MRL proposal of 4 mg/kg for cyprodinil in Florence fennel. Adequate analytical methods for enforcement are availa...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-3-2019

Kingston Pharma, LLC RECALLS " DG™/health NATURALS baby Cough Syrup + Mucus”  Because of Possible Health Risk

Kingston Pharma, LLC RECALLS " DG™/health NATURALS baby Cough Syrup + Mucus” Because of Possible Health Risk

Kingston Pharma, LLC of Massena, NY is recalling Lot KL180157 of its 2-fluid ounce (59 mL) bottles of DG™/health NATURALS baby Cough Syrup + Mucus” because it has the potential to be contaminated with Bacillus cereus/ Bacillus circulans. Bacillus cereus in food products has the potential to produce two forms of gastrointestinal illness, one being a syndrome primarily of vomiting, and the other of diarrhea. Most often, illnesses are mild and self-limiting, although more serious and even lethal cases have...

FDA - U.S. Food and Drug Administration

20-3-2019

Safety and efficacy of eight compounds belonging to different chemical groups when used as flavourings for cats and dogs

Safety and efficacy of eight compounds belonging to different chemical groups when used as flavourings for cats and dogs

Published on: Tue, 19 Mar 2019 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of 23 compounds belonging to different chemical groups. This opinion concerns eight out of the 23 compounds, which are currently authorised for use as flavours in food. The Panel concludes that the eight additives are safe for cats and dogs at the proposed use level: phenyl...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-3-2019

Safety and efficacy of 26 compounds belonging to chemical group 3 (α,β‐unsaturated straight‐chain and branched‐chain aliphatic primary alcohols, aldehydes, acids and esters) when used as flavourings for all animal species and categories

Safety and efficacy of 26 compounds belonging to chemical group 3 (α,β‐unsaturated straight‐chain and branched‐chain aliphatic primary alcohols, aldehydes, acids and esters) when used as flavourings for all animal species and categories

Published on: Tue, 19 Mar 2019 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of 26 compounds belonging to chemical group 3 (α,β‐unsaturated straight‐chain and branched‐chain aliphatic primary alcohols, aldehydes, acids and esters). They are all currently authorised as flavours in food. The FEEDAP Panel was unable to perform the assessment of non‐2(c...

Europe - EFSA - European Food Safety Authority EFSA Journal

18-3-2019

Mylan Institutional LLC Initiates Voluntary Nationwide Recall of Levoleucovorin Injection Due to the Presence of Particulate Matter

Mylan Institutional LLC Initiates Voluntary Nationwide Recall of Levoleucovorin Injection Due to the Presence of Particulate Matter

Mylan Institutional LLC is conducting a voluntary nationwide recall of two lots (see table below) of Levoleucovorin Injection, 250 mg/25 mL to the consumer/user level. The lots were manufactured by Alidac Pharmaceuticals Limited and distributed by Mylan Institutional LLC.

FDA - U.S. Food and Drug Administration

16-3-2019

Efficacy of sodium formate as a technological feed additive (hygiene condition enhancer) for all animal species

Efficacy of sodium formate as a technological feed additive (hygiene condition enhancer) for all animal species

Published on: Fri, 15 Mar 2019 In 2015, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) issued an opinion on the safety and efficacy of formic acid, ammonium formate and sodium formate as feed hygiene agents for all animal species. In this opinion, two forms of the additive sodium formate, a solid form (specified to contain ≥ 98% sodium formate (w/w)) and a liquid form (specified to contain a minimum of 15% sodium formate, a maximum of 75% free formic acid and a maxim...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-3-2019

Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 50mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical Ingredient

Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 50mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical Ingredient

Legacy Pharmaceutical Packaging, LLC is recalling 3 repackaged lots of Losartan Tablets USP 50mg to the consumer level. This recall was prompted due to Torrent Pharmaceuticals LTD issuing a Voluntary Nationwide Recall of Losartan Tablets, USP, due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, (API manufacturer).

FDA - U.S. Food and Drug Administration

16-3-2019

Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25mg, 50mg, And 100mg Due to The Detection of Trace Amounts Of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) Impurity Found in The Active Pharmace

Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25mg, 50mg, And 100mg Due to The Detection of Trace Amounts Of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) Impurity Found in The Active Pharmace

Earth City, MO, Legacy Pharmaceutical Packaging, LLC is recalling 40 repackaged lots of Losartan Tablets USP 25mg, 50mg, and 100mg to the consumer level. This recall was prompted due to Camber Pharmaceuticals, Inc. issuing a Voluntary Nationwide Recall of Losartan Tablets, USP, due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, (API manufacturer).

FDA - U.S. Food and Drug Administration

15-3-2019

Hospira, Inc. Issues a Voluntary Nationwide Recall of 8.4% Sodium Bicarbonate Injection, USP Due to the Presence of Particulate Matter

Hospira, Inc. Issues a Voluntary Nationwide Recall of 8.4% Sodium Bicarbonate Injection, USP Due to the Presence of Particulate Matter

Hospira, Inc., a Pfizer company, is voluntarily recalling lot numbers 79-238-EV, 79-240-EV and 80-088-EV, NDC# 0409-6625-02, of 8.4% Sodium Bicarbonate Injection USP, 50 mEq/50 mL (1 mEq/mL), to the Hospital/Institution level. The recall was initiated due to the presence of particulate matter, confirmed as glass.

FDA - U.S. Food and Drug Administration

15-3-2019

Modification of the existing maximum residue level for fluopyram in broccoli

Modification of the existing maximum residue level for fluopyram in broccoli

Published on: Thu, 14 Mar 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer Hellas AG submitted a request to the competent national authority in Greece to modify the existing maximum residue level (MRL) for the active substance fluopyram in broccoli. The data submitted in support of the request were found to be sufficient to derive MRL proposals for broccoli. Adequate analytical methods for enforcement are available to control the residues of fluopyram on the commodit...

Europe - EFSA - European Food Safety Authority EFSA Journal

14-3-2019

Safety of annatto E and the exposure to the annatto colouring principles bixin and norbixin (E 160b) when used as a food additive

Safety of annatto E and the exposure to the annatto colouring principles bixin and norbixin (E 160b) when used as a food additive

Published on: Wed, 13 Mar 2019 The Scientific Panel on Food Additives and Flavouring (FAF) provides a scientific opinion on the safety evaluation of annatto E and an exposure assessment of the annatto colouring principles bixin and norbixin (E 160b) when used as a food additive, taking into account new proposed uses and use levels. In 2016, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) adopted a scientific opinion on the safety of annatto extracts (E 160b) as a food additive....

Europe - EFSA - European Food Safety Authority EFSA Journal

14-3-2019

Safety evaluation of the food enzyme β‐glucanase, xylanase and cellulase from Mycothermus thermophiloides (strain NZYM‐ST)

Safety evaluation of the food enzyme β‐glucanase, xylanase and cellulase from Mycothermus thermophiloides (strain NZYM‐ST)

Published on: Fri, 08 Mar 2019 The food enzyme has three declared activities (endo‐1,3(4)‐β‐glucanase EC 3.2.1.6, endo‐1,4‐β‐xylanase EC 3.2.1.8 and cellulase (endo‐1,4‐β‐d‐glucanase EC 3.2.1.4)) and is produced with a non‐genetically modified Mycothermus thermophiloides strain by Novozymes A/S. It is intended to be used in baking and brewing processes. For the two intended uses, based on the maximum use levels recommended and individual data from the EFSA Comprehensive European Food Database, dietary e...

Europe - EFSA - European Food Safety Authority EFSA Journal

13-3-2019

Safety evaluation of the food enzyme triacylglycerol lipase from Aspergillus niger (strain LFS)

Safety evaluation of the food enzyme triacylglycerol lipase from Aspergillus niger (strain LFS)

Published on: Tue, 12 Mar 2019 The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase, EC 3.1.1.3) is produced with a genetically modified Aspergillus niger strain LFS by DSM Food Specialties B.V.. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The triacylglycerol lipase food enzyme is intended to be used in baking processes. Based on the maximum use levels, dietary exposure to the fo...

Europe - EFSA - European Food Safety Authority EFSA Journal

13-3-2019

Safety evaluation of the food enzyme glucose oxidase from Aspergillus niger (strain ZGL)

Safety evaluation of the food enzyme glucose oxidase from Aspergillus niger (strain ZGL)

Published on: Tue, 12 Mar 2019 The food enzyme glucose oxidase (β‐d‐glucose:oxygen 1‐oxidoreductase; EC 1.1.3.4) is produced with a genetically modified Aspergillus niger strain ZGL by DSM Food Specialties B.V.. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The glucose oxidase is intended to be used in baking processes. Based on the maximum use levels, dietary exposure to the food enzyme‐total orga...

Europe - EFSA - European Food Safety Authority EFSA Journal

9-3-2019

Safety evaluation of the food enzyme 4‐α‐glucanotransferase from Aeribacillus pallidus (strain AE‐SAS)

Safety evaluation of the food enzyme 4‐α‐glucanotransferase from Aeribacillus pallidus (strain AE‐SAS)

Published on: Fri, 08 Mar 2019 The food enzyme 4‐α‐glucanotransferase (1,4‐α‐d‐glucan:1,4‐α‐d‐glucan 4‐α‐d‐glycosyltransferase, EC 2.4.1.25) is produced with a non‐genetically modified Aeribacillus pallidus (previously identified as Geobacillus pallidus) strain from Amano Enzyme Inc. The food enzyme is intended to be used in baking processes and in starch processing for the production of modified dextrins. For baking processes, based on the maximum use levels recommended and individual data from the EFS...

Europe - EFSA - European Food Safety Authority EFSA Journal

9-3-2019

Safety of ethyl lauroyl arginate (E 243) as a food additive in the light of the new information provided and the proposed extension of use

Safety of ethyl lauroyl arginate (E 243) as a food additive in the light of the new information provided and the proposed extension of use

Published on: Fri, 08 Mar 2019 The present scientific opinion deals with the evaluation of the safety of the food additive ethyl lauroyl arginate (E 243) in the light of a new interpretation of the available toxicological data and with respect to the proposed changes to the currently authorised conditions of use. Ethyl lauroyl arginate (E 243) is an already authorised food additive in the EU for use in heat‐treated meat products only, with some exceptions. The safety of ethyl lauroyl arginate (E 243) as...

Europe - EFSA - European Food Safety Authority EFSA Journal

8-3-2019


Draft Colchicine tablet 0.5 mg and 1 mg product-specific bioequivalence guidance

Draft Colchicine tablet 0.5 mg and 1 mg product-specific bioequivalence guidance

Draft Colchicine tablet 0.5 mg and 1 mg product-specific bioequivalence guidance

Europe - EMA - European Medicines Agency

7-3-2019

American Health Packaging Issues Voluntary Nationwide Recall of Valsartan Tablets Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity

American Health Packaging Issues Voluntary Nationwide Recall of Valsartan Tablets Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity

American Health Packaging is voluntarily recalling one lot of Valsartan Tablets, USP, 160 mg to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. The impurity detected in the finished drug product is N-Nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Resea...

FDA - U.S. Food and Drug Administration

7-3-2019

Re‐evaluation of Quillaia extract (E 999) as a food additive and safety of the proposed extension of use

Re‐evaluation of Quillaia extract (E 999) as a food additive and safety of the proposed extension of use

Published on: Wed, 06 Mar 2019 The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion on Quillaia extract (E 999) when used as a food additive and the evaluation of the safety of its proposed extension of use as a food additive in flavourings. The Scientific Committee for Food (SCF) in 1978 established an acceptable daily intake (ADI) of 0–5 mg spray‐dried extract/kg body weight (bw) per day for E 999. The Joint FAO/WHO Expert Committee on Food Additives ...

Europe - EFSA - European Food Safety Authority EFSA Journal

7-3-2019

Safety and efficacy of Robenz® 66G (robenidine hydrochloride) for chickens for fattening and turkeys for fattening

Safety and efficacy of Robenz® 66G (robenidine hydrochloride) for chickens for fattening and turkeys for fattening

Published on: Tue, 05 Mar 2019 Following a request from European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Robenz® 66G (robenidine hydrochloride (HCl)) when used as a feed additive for chickens for fattening and turkeys for fattening. The coccidiostat Robenz®66G is considered safe for chickens for fattening at the highest proposed level of 36 mg robenidine HCl/kg complete feed with a ...

Europe - EFSA - European Food Safety Authority EFSA Journal

5-3-2019

Morphine Sulfate Injection BP 30 mg in 1 mL ampoule

Morphine Sulfate Injection BP 30 mg in 1 mL ampoule

Safety advisory – Section 19A product not for epidural or intrathecal use

Therapeutic Goods Administration - Australia

5-3-2019

Safety and efficacy of Beltherm MP/ML (endo-1,4-betaxylanase) as a feed additive for piglets, pigs for fattening and other porcine species

Safety and efficacy of Beltherm MP/ML (endo-1,4-betaxylanase) as a feed additive for piglets, pigs for fattening and other porcine species

Published on: Mon, 04 Mar 2019 Beltherm MP/ML contains endo-1,4-beta-xylanase and it is to be used as a zootechnical additive for weaned piglets, pigs for fattening and minor porcine species for fattening. The safety and efficacy of the additive when used for poultry species have been evaluated previously by the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel). In that assessment, the safety for the consumers, environment and the users was assessed. The applicant has ...

Europe - EFSA - European Food Safety Authority EFSA Journal

5-3-2019

Safety and efficacy of Beltherm MP/ML (endo‐1,4‐beta‐xylanase) as a feed additive for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding, turkeys for breeding purposes and minor poultry species

Safety and efficacy of Beltherm MP/ML (endo‐1,4‐beta‐xylanase) as a feed additive for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding, turkeys for breeding purposes and minor poultry species

Published on: Fri, 01 Mar 2019 Beltherm MP/ML contains endo‐1,4‐beta‐xylanase and is intended to be used as a zootechnical additive for poultry species. The safety and efficacy of the additive have been evaluated by the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) in 2017. In that assessment, the additive and the production strain, a genetically modified strain of Bacillus subtilis, were characterised in full. No viable cells of the production strain were detecte...

Europe - EFSA - European Food Safety Authority EFSA Journal

5-3-2019

Opinion on the follow‐up of the re‐evaluation of sorbic acid (E200) and potassium sorbate (E202) as food additives

Opinion on the follow‐up of the re‐evaluation of sorbic acid (E200) and potassium sorbate (E202) as food additives

Published on: Fri, 01 Mar 2019 In this opinion, the EFSA Panel on Food Additives and Flavourings (FAF Panel) was requested by the European Commission to carry out a scientific evaluation of an extended one‐generation reproductive toxicity study (EOGRTS) to determine whether it would allow reconsideration of the temporary group acceptable daily intake (ADI) for sorbic acid (E 200) and potassium sorbate (E 202), established by the Panel on Food Additives and Nutrient Sources added to Food (ANS Panel) in 2...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-3-2019

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25 mg, 50 mg and 100 mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25 mg, 50 mg and 100 mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical

Camber Pharmaceuticals, Inc. is recalling 87 lots of Losartan Tablets USP 25 mg, 50 mg, and 100 mg to consumer level. This recall was prompted due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, Unit – I (API manufacturer).

FDA - U.S. Food and Drug Administration

26-2-2019

Safety and efficacy of TYFER™ (ferric tyrosine chelate) as a zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breading

Safety and efficacy of TYFER™ (ferric tyrosine chelate) as a zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breading

Published on: Mon, 25 Feb 2019 Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the product TYFER™ (ferric tyrosine chelate) as zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breeding. The additive is safe for chickens for fattening at the maximum expected level of 200 mg TYFER™/kg complete feed; this conclusion can be extended to chickens reared for laying/breedin...

Europe - EFSA - European Food Safety Authority EFSA Journal

26-2-2019

Safety and efficacy of a molybdenum compound (E7) sodium molybdate dihydrate as feed additive for sheep based on a dossier submitted by Trouw Nutrition International B.V.

Safety and efficacy of a molybdenum compound (E7) sodium molybdate dihydrate as feed additive for sheep based on a dossier submitted by Trouw Nutrition International B.V.

Published on: Mon, 25 Feb 2019 No abstract available. © European Food Safety Authority, 2015 Safety and efficacy of a molybdenum compound (E7) sodium molybdate dihydrate as feed additive for sheep based on a dossier submitted by Trouw Nutrition International B.V.

Europe - EFSA - European Food Safety Authority EFSA Journal

25-2-2019

Macleods Pharmaceuticals Limited Issues Voluntary Nationwide Consumer Level Recall of One Lot (BLM 715A) of Losartan Potassium/Hydrochlorothiazide Combination Tablets 100mg/25mg Due to detection of NDEA (N-Nitrosodiethylamine) Impurity

Macleods Pharmaceuticals Limited Issues Voluntary Nationwide Consumer Level Recall of One Lot (BLM 715A) of Losartan Potassium/Hydrochlorothiazide Combination Tablets 100mg/25mg Due to detection of NDEA (N-Nitrosodiethylamine) Impurity

Macleods Pharmaceuticals Limited is voluntarily recalling one lot of Losartan Potassium/Hydrochlorothiazide combination tablets 100mg/25mg to the consumer level due to the detection of trace amounts of an unexpected impurity (NDEA) found in finished product manufactured with active pharmaceutical ingredient made by Hetero Labs Limited.

FDA - U.S. Food and Drug Administration

25-2-2019

Xeljanz, Xeljanz XR (tofacitinib): Safety Communication - Safety Trial Finds Increased Risk of Blood Clots in the Lungs and Death with Higher Dose in Rheumatoid Arthritis Patients

Xeljanz, Xeljanz XR (tofacitinib): Safety Communication - Safety Trial Finds Increased Risk of Blood Clots in the Lungs and Death with Higher Dose in Rheumatoid Arthritis Patients

FDA is alerting the public that a safety clinical trial found an increased risk of blood clots in the lungs and death when a 10 mg twice daily dose of tofacitinib (Xeljanz, Xeljanz XR) was used in patients with rheumatoid arthritis (RA). FDA has not approved this 10 mg twice daily dose for RA; this dose is only approved in the dosing regimen for patients with ulcerative colitis

FDA - U.S. Food and Drug Administration

14-2-2019

Modification of the existing maximum residue levels for mandipropamid in various crops

Modification of the existing maximum residue levels for mandipropamid in various crops

Published on: Wed, 13 Feb 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants Syngenta Crop Protection B.V. and Agriculture and Horticulture Development Board (AHDB) submitted, respectively, a request to the competent national authorities in the Netherlands and United Kingdom to modify the existing maximum residue levels (MRLs) for the active substance mandipropamid in various crops. The data submitted in support of the request were found to be sufficient to derive MRL propo...

Europe - EFSA - European Food Safety Authority EFSA Journal

4-2-2019

Dr. Reddy's Laboratories Continues its Voluntary Nationwide Recall of Levetiracetam in 0.54% Sodium Chloride Injection 1500mg/100mL Due to Mislabeling

Dr. Reddy's Laboratories Continues its Voluntary Nationwide Recall of Levetiracetam in 0.54% Sodium Chloride Injection 1500mg/100mL Due to Mislabeling

Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) announced that it’s wholly owned subsidiary, Dr Reddy’s Laboratories, Inc is continuing its voluntary nationwide recall of lot ABD807 of Levetiracetram in 0.54% Sodium Chloride Injection, 1,500 mg/100 mL (15 mg/mL) single-dose infusion bags to the hospital level in U.S.A.

FDA - U.S. Food and Drug Administration

30-1-2019

Tris Pharma, Inc Expands Its Voluntary Nationwide Retail Recall of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, Due to Higher Concentration of Ibuprofen

Tris Pharma, Inc Expands Its Voluntary Nationwide Retail Recall of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, Due to Higher Concentration of Ibuprofen

Monmouth Junction, NJ, Tris Pharma, Inc. is expanding the scope of its November 2018 recall by adding three (3) additional lots of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, to the retail (pharmacy) level. Some units from these batches have been found to have higher levels of Ibuprofen concentration.

FDA - U.S. Food and Drug Administration

21-3-2019

In addition, the FDA is providing a live feed of the meeting for those who cannot attend in person: March 25, 2019 (Day 1) Webcast:  https://bit.ly/2WgkmGC   March 26, 2019 (Day 2) Webcast: https://bit.ly/2TnAKU0   #FDA #MedicalDevicepic.twitter.com/zvhd7

In addition, the FDA is providing a live feed of the meeting for those who cannot attend in person: March 25, 2019 (Day 1) Webcast: https://bit.ly/2WgkmGC  March 26, 2019 (Day 2) Webcast: https://bit.ly/2TnAKU0  #FDA #MedicalDevicepic.twitter.com/zvhd7

In addition, the FDA is providing a live feed of the meeting for those who cannot attend in person: March 25, 2019 (Day 1) Webcast: https://bit.ly/2WgkmGC  March 26, 2019 (Day 2) Webcast: https://bit.ly/2TnAKU0  #FDA #MedicalDevice pic.twitter.com/zvhd72SyxX

FDA - U.S. Food and Drug Administration

21-3-2019

The @US_FDA is committed to protecting and promoting the public’s health. On March 25-26, the agency will host the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting. #FDA #MedicalDevicepic.twitter.com/Wh9Sshjn6n

The @US_FDA is committed to protecting and promoting the public’s health. On March 25-26, the agency will host the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting. #FDA #MedicalDevicepic.twitter.com/Wh9Sshjn6n

The @US_FDA is committed to protecting and promoting the public’s health. On March 25-26, the agency will host the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting. #FDA #MedicalDevice pic.twitter.com/Wh9Sshjn6n

FDA - U.S. Food and Drug Administration

18-3-2019


Orphan designation: Amikacin sulfate (liposomal), Treatment of Pseudomonas aeruginosa lung infection in cystic fibrosis, 25/07/2006, Positive

Orphan designation: Amikacin sulfate (liposomal), Treatment of Pseudomonas aeruginosa lung infection in cystic fibrosis, 25/07/2006, Positive

Orphan designation: Amikacin sulfate (liposomal), Treatment of Pseudomonas aeruginosa lung infection in cystic fibrosis, 25/07/2006, Positive

Europe - EMA - European Medicines Agency

13-3-2019

Stayveer (Janssen Pharmaceutica N.V.)

Stayveer (Janssen Pharmaceutica N.V.)

Stayveer (Active substance: bosentan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2065 of Wed, 13 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/2644/T/25

Europe -DG Health and Food Safety

8-3-2019

Public submissions on scheduling matters referred to the ACMS #25, ACCS #23 and Joint ACMS-ACCS #20 meetings held in November 2018

Public submissions on scheduling matters referred to the ACMS #25, ACCS #23 and Joint ACMS-ACCS #20 meetings held in November 2018

Public submissions on scheduling matters referred to ACMS/ACCS meetings held in November 2018

Therapeutic Goods Administration - Australia

25-2-2019

Vabomere (Menarini International Operations Luxembourg S.A.)

Vabomere (Menarini International Operations Luxembourg S.A.)

Vabomere (Active substance: meropenem/vaborbactam) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1591 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/004669/T/0001

Europe -DG Health and Food Safety

25-2-2019

Zulvac BTV (Zoetis Belgium S.A.)

Zulvac BTV (Zoetis Belgium S.A.)

Zulvac BTV (Active substance: Bluetongue virus vaccine (inactivated) (multistrain: 1 strain out of a set of 3)) - Centralised - Variation - Commission Decision (2019)1607 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/4185/X/01

Europe -DG Health and Food Safety

25-2-2019

EU/3/17/1880 (Chemocentryx Ireland Limited)

EU/3/17/1880 (Chemocentryx Ireland Limited)

EU/3/17/1880 (Active substance: Avacopan) - Transfer of orphan designation - Commission Decision (2019)1618 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004221

Europe -DG Health and Food Safety

25-2-2019

EU/3/10/732 (Southwood Research Limited)

EU/3/10/732 (Southwood Research Limited)

EU/3/10/732 (Active substance: Entinostat) - Transfer of orphan designation - Commission Decision (2019)1631 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004131

Europe -DG Health and Food Safety

25-2-2019

EU/3/05/301 (Taro Pharmaceuticals Europe B.V.)

EU/3/05/301 (Taro Pharmaceuticals Europe B.V.)

EU/3/05/301 (Active substance: Chimeric monoclonal antibody to shiga-toxin 1 and 2) - Transfer of orphan designation - Commission Decision (2019)1636 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003835

Europe -DG Health and Food Safety

25-2-2019

EU/3/05/288 (Teva  GmbH)

EU/3/05/288 (Teva GmbH)

EU/3/05/288 (Active substance: 4-[3-(methylsulfonyl)phenyl]-1-propylpiperidine x HCl) - Transfer of orphan designation - Commission Decision (2019)1635 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003804

Europe -DG Health and Food Safety

25-2-2019

EU/3/16/1674 (Bellicum Pharma GmbH)

EU/3/16/1674 (Bellicum Pharma GmbH)

EU/3/16/1674 (Active substance: Allogeneic donor-derived ex-vivo expanded T lymphocytes transduced with a retroviral vector containing inducible caspase 9 and truncated CD19) - Transfer of orphan designation - Commission Decision (2019)1630 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004083

Europe -DG Health and Food Safety

25-2-2019

EU/3/16/1666 (Bellicum Pharma GmbH)

EU/3/16/1666 (Bellicum Pharma GmbH)

EU/3/16/1666 (Active substance: Rimiducid) - Transfer of orphan designation - Commission Decision (2019)1629 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004057

Europe -DG Health and Food Safety

25-2-2019

EU/3/15/1526 (Ultragenyx Netherlands B.V.)

EU/3/15/1526 (Ultragenyx Netherlands B.V.)

EU/3/15/1526 (Active substance: Triheptanoin) - Transfer of orphan designation - Commission Decision (2019)1632 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003558

Europe -DG Health and Food Safety

25-2-2019

EU/3/12/1091 (bluebird bio (Netherlands) B.V.)

EU/3/12/1091 (bluebird bio (Netherlands) B.V.)

EU/3/12/1091 (Active substance: Autologous CD34+ haematopoietic stem cells transduced with lentiviral vector encoding the human betaA-T87Q-globin gene) - Transfer of orphan designation - Commission Decision (2019)1626 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003556

Europe -DG Health and Food Safety

25-2-2019

EU/3/12/1003 (bluebird bio (Netherlands) B.V.)

EU/3/12/1003 (bluebird bio (Netherlands) B.V.)

EU/3/12/1003 (Active substance: Autologous haematopoietic stem cells transduced with lentiviral vector Lenti-D encoding the human ABCD1 cDNA) - Transfer of orphan designation - Commission Decision (2019)1634 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003636

Europe -DG Health and Food Safety

25-2-2019

EU/3/18/2026 (Alnylam Netherlands B.V.)

EU/3/18/2026 (Alnylam Netherlands B.V.)

EU/3/18/2026 (Active substance: Synthetic double-stranded siRNA oligonucleotide targeted against transthyretin mRNA, with six phosphorothioate linkages in the backbone, and nine 2'-fluoro and thirty-five 2'-O-methyl nucleoside residues in the sequence, which is covalently linked via a phosphodiester group to a ligand containing three N-acetylgalactosamine residues) - Transfer of orphan designation - Commission Decision (2019)1637 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/O...

Europe -DG Health and Food Safety

25-2-2019

EU/3/15/1518 (Novartis Europharm Limited)

EU/3/15/1518 (Novartis Europharm Limited)

EU/3/15/1518 (Active substance: Adenovirus-associated viral vector serotype 2 containing the human RPE65 gene) - Transfer of orphan designation - Commission Decision (2019)1628 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003549

Europe -DG Health and Food Safety

25-2-2019

EU/3/12/981 (Novartis Europharm Limited)

EU/3/12/981 (Novartis Europharm Limited)

EU/3/12/981 (Active substance: Adenovirus associated viral vector serotype 2 containing the human RPE65 gene) - Transfer of orphan designation - Commission Decision (2019)1627 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003485

Europe -DG Health and Food Safety

25-2-2019

EU/3/16/1637 (Alnylam Netherlands B.V.)

EU/3/16/1637 (Alnylam Netherlands B.V.)

EU/3/16/1637 (Active substance: Synthetic double-stranded siRNA oligonucleotide directed against hydroxyacid oxidase 1 mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues) - Transfer of orphan designation - Commission Decision (2019)1633 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003680

Europe -DG Health and Food Safety

25-2-2019

BLUEVAC BTV8 (CZ Veterinaria, S.A.)

BLUEVAC BTV8 (CZ Veterinaria, S.A.)

BLUEVAC BTV8 (Active substance: Bluetongue virus inactivated, serotype 8) - Centralised - Yearly update - Commission Decision (2019)1610 of Mon, 25 Feb 2019

Europe -DG Health and Food Safety

25-2-2019

EU/3/14/1259 (Insmed Netherlands B.V.)

EU/3/14/1259 (Insmed Netherlands B.V.)

EU/3/14/1259 (Active substance: Amikacin sulfate) - Transfer of orphan designation - Commission Decision (2019)1625 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003885

Europe -DG Health and Food Safety

25-2-2019

EU/3/06/387 (Insmed Netherlands B.V.)

EU/3/06/387 (Insmed Netherlands B.V.)

EU/3/06/387 (Active substance: Amikacin sulfate (liposomal)) - Transfer of orphan designation - Commission Decision (2019)1624 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003770

Europe -DG Health and Food Safety

25-2-2019

EU/3/14/1373 (Chemocentryx Ireland Limited)

EU/3/14/1373 (Chemocentryx Ireland Limited)

EU/3/14/1373 (Active substance: (2R,3S)-2-(4-cyclopentylaminophenyl)-1-(2-fluoro-6-methylbenzoyl)piperidine-3-carboxylic acid(4-methyl-3-trifluoromethylphenyl)amide) - Transfer of orphan designation - Commission Decision (2019)1619 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004220

Europe -DG Health and Food Safety

25-2-2019

EU/3/14/1372 (Chemocentryx Ireland Limited)

EU/3/14/1372 (Chemocentryx Ireland Limited)

EU/3/14/1372 (Active substance: (2R,3S)-2-(4-cyclopentylaminophenyl)-1-(2-fluoro-6-methylbenzoyl)piperidine-3-carboxylic acid(4-methyl-3-trifluoromethylphenyl)amide) - Transfer of orphan designation - Commission Decision (2019)1620 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004218

Europe -DG Health and Food Safety

22-2-2019


Orphan designation: Autologous CD4+ and CD8+ T cells expressing a CD19-specific chimeric antigen receptor, Treatment of follicular lymphoma, 25/05/2018, Positive

Orphan designation: Autologous CD4+ and CD8+ T cells expressing a CD19-specific chimeric antigen receptor, Treatment of follicular lymphoma, 25/05/2018, Positive

Orphan designation: Autologous CD4+ and CD8+ T cells expressing a CD19-specific chimeric antigen receptor, Treatment of follicular lymphoma, 25/05/2018, Positive

Europe - EMA - European Medicines Agency

21-2-2019


Orphan designation: Becatecarin, Treatment of cancers of the biliary tree, 25/07/2006, Withdrawn

Orphan designation: Becatecarin, Treatment of cancers of the biliary tree, 25/07/2006, Withdrawn

Orphan designation: Becatecarin, Treatment of cancers of the biliary tree, 25/07/2006, Withdrawn

Europe - EMA - European Medicines Agency

18-2-2019

Imatinib Accord (Accord Healthcare S.L.U.)

Imatinib Accord (Accord Healthcare S.L.U.)

Imatinib Accord (Active substance: Imatinib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1434 of Mon, 18 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/2681/T/25

Europe -DG Health and Food Safety

15-2-2019

Today, the @US_FDA announced an upcoming General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting that will take place on March 25-26. Learn more about the details and how to attend here:  https://go.usa.gov/xEUeu  #Medi

Today, the @US_FDA announced an upcoming General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting that will take place on March 25-26. Learn more about the details and how to attend here: https://go.usa.gov/xEUeu  #Medi

Today, the @US_FDA announced an upcoming General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting that will take place on March 25-26. Learn more about the details and how to attend here: https://go.usa.gov/xEUeu  #MedicalDevice #FDA

FDA - U.S. Food and Drug Administration

1-2-2019

Diotop 75 mg / 20 mg modified-release capsules, hard and associated names

Diotop 75 mg / 20 mg modified-release capsules, hard and associated names

Diotop 75 mg / 20 mg modified-release capsules, hard and associated names (Active substance: diclofenac/omeprazole) - Community Referrals - Art 29 - Commission Decision (2019)845 of Fri, 01 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/A-29(4)/1474

Europe -DG Health and Food Safety